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U.S. Department of Health and Human Services

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FDAAA Implementation Chart

For additional information about the implementation of the Prescription Drug User Fee Act (PDUFA) IV and the Medical Device User Fee and Modernization Act (MDUFMA) please go to these FDA web sites: 

SECTIONDESCRIPTIONTARGET DATEACTIONS COMPLETED/ DOCUMENTS AVAILABLEAGENCY CONTACT
103Workload adjuster modified to user active INDs08-01-2008Completed
Federal Register notice published 10/12/07
HTML or PDF
OC/OFM – David Miller
103Contract with independent accounting firm to study workload adjuster & make recommendations10-31-2008Contract awarded 8/14/08. Study was completed on 3/31/09.
HTML or PDF
OC/OPPP – John Hassenplug and Bill Hagan
104Publish FR notice NLT 30 days after enactment requesting persons to notify Secty of number of DTC ads they intend to submit in next fy10-25-2007Published Federal Register Notice of termination 10/25/2007
HTML or PDF
CDER – Tom Abrams
104Publish fees for DTC review NLT 90 days after enactment in FY08 and NLT August 1 in each FY after FY0812-26-2007Program no longer exists. Published Federal Register Notice of termination 1/16/2008
HTML or PDF
CDER- Tom Abrams
104If Secretary has not received $11.25M in advisory review fees and operating reserves combined the program shall not commence and all collected fees shall be refunded02-26-2009Program no longer exists. Published Federal Register Notice of termination 1/16/2008
HTML or PDF
CDER – Tom Abrams
105Prepare and submit to SenateHELP and House E&C Committees report on progress in achieving performance goals01-28-2009 OC
105Report on implementation of fees during such fiscal year01-28-2009 OPPP
105Prior to beginning negotiations with regulated industry on reauthorization of PDUFA after 2012, the secretary shall publish an FR notice requesting public input on the reauthorization03-01-2010 OPPP
105Prior to beginning negotiations with regulated industry on reauthorization of PDUFA after 2012, the secretary shall hold a public meeting at which public may present views on reauthorization06-01-2010 OPPP
105Public Review of Recommendations for PDUFA V--after negotiations with industry Secty shall publish recs, provide 30 day comment period and hold public meeting; revise recs as necessary09-01-2011 OPPP
105Transmittal of revised recommendations to Congress01-15-2012 OPPP
105Publication of minutes of all negotiation meetings on FDA's web site08-01-2011 OPPP
212If fewer than 12,250 establishments register during FY 2009, FDA may increase the annual establishment registration fee for FYs 2010 through 2012 by no more than an additional 8.5%; If FDA increases the fee, publish a Federal Register explaining the increase.08-01-2009 CDRH – Terry McDonald
212Provide a means for a foreign business not submitting Federal (U.S) income tax return to qualify as a "small business"10-27-2007Completed
FDA has posted new guidance on MDUFMA web site
HTML or PDF
FR Notice published 10/23/07
HTML or PDF
Division of Small Manufacturers, International, and Consumer Assistance 800-638-2041
212Determine whether medical device user fees for FY 2012 must be reduced to offset excess fee collections during FYs 2008 through 2011.8-1-2011 OFM
213Annual performance report to Congress01-28-2009 OPPP/OPL – John Uzzell
213Annual fiscal report to Congress01-28-2009 OFM - David Miller
213Make annual fiscal and performance reports available to the public on FDA's web site2-28-2009 (Fiscal Report) OFM - David Miller(Performance Report) OPPP/OPL – John Uzzell
213Consult with Congress, outside stakeholders, and public to develop recommendations for MDUFA goals for reauthorization for years after 2012. Transmit recommendations to Congress. Before submission to Congress, publish an FR notice, hold a public meeting, and allow for 30 days to pass following the public meeting for written comment, and consult with public and patient groups at least once a month during negotiations. Provide minutes from all reauthorization negotiation meetings on FDA's web site.01-15-2012 OC
222Registration 

Federal Register notice on Agency Information Collection Activities published 10/1/08
HTML or PDF

Federal Register notice on Agency Information Collection Activities published 12/12/08
HTML or PDF

OC/OIM - Denver Presley, Jr.
223Filing of lists of drugs and devices manufactured, prepared, propagated, and compounded by registrants 

Federal Register notice on Agency Information Collection Activities published 10/1/08
HTML or PDF

Federal Register notice on Agency Information Collection Activities published 12/12/08
HTML or PDF

OC/OIM - Denver Presley, Jr.
224Electronic registration and listing 

Federal Register notice on Agency Information Collection Activities published 10/1/08
HTML or PDF

Federal Register notice on Agency Information Collection Activities published 12/12/08
HTML or PDF

Federal Register notice on final guidance published 6/1/09
HTML or PDF
Final Guidance

OC/OIM - Denver Presley, Jr.
226Promulgate regulations requiring the label of devices to bear a unique identifier 2/12/09 Public Workshop Notice published on 1/15/09; comments due 2/27/09
HTML or PDF
CDRH – Jay Crowley
228Revise guidance on third-party inspection program to reflect changes relating to notice to be provided that an accredited person may not be used; information FDA may request about compliance or an accredited person; and how to obtain review of an FDA decision to disqualify accredited person  CDRH – John Stigi
229GAO shall conduct a study of nosocomial infections attributable to new and reused medical devices09-27-2008GAO study published 9/26/08
HTML or PDF
OC - Claudia Grillo
230Report to Congress on labeling on the relationship between the use of indoor tanning devices and development of skin cancer/damage09-27-2008Report to Congress sent 12/2/08
HTML or PDF
CDRH – John McCrohan
302Annual report on number of devices related to pediatrics03-27-2009 CDRH – Barbara Buch
303Guidance to institutional review committees on how to evaluate requests for approval of exempted devices03-25-2008Federal Register Notice published on 8/5/08; comments due 11/3/08
HTML or PDF
CDRH – Stephen Rhodes
304FDA supporting lead of NIH to submit a plan for expanding pediatric medical device research & development to Congress.03-25-2008Draft Pediatric Device Development Plan (PDF) dated June 2008 published on NIH web siteCDRH and OC
305

Demonstration grants for improving pediatric device availability.
 

 

 

Pediatric Device Consortia Grant Program Request for Applications Federal Register Notice published 5/4/09; applications due 6/15/09
HTML or PDF

 

Four pediatric medical device consortia grants have been awarded by Office of Orphan Products Development. Grantees include Michigan Pediatric Device Consortium;  the Pediatric Cardiovascular Device Consortium at Boston Children's Hospital; the UCSF Pediatric Device Cosortium; and SRI International's MISTRAL constortium.

OC/OOPD - Linda C. Ulrich or Debra Y. Lewis 

 

402PeRC (Pediatric Review Committee/Internal Review Committee) shall conduct a retrospective review of a sample of waivers and deferrals, and shall issue recommendations to review divisions based on Committee's review Retrospective Review completed available at PDFCDER – Lisa Mathis
402Tracking of Assessments and Labeling Changes in a public information web site Labeling changes web site formulated and located at Pediatric Exclusivity Labeling Changes.CDER – Lisa Mathis
402Initiate guidance to industry related to the scope of pediatric studies required under PREA based on retrospective review08-31-2010Status: Guidance drafted and has begun final clearance.CDER – Lisa Mathis
403Establish an internal committee within FDA to review both BPCA and PREA related activities10-27-2007Created CommitteeCDER – Lisa Mathis
502Toll-Free Number for Adverse Events on Labeling for Human Drug Products - Proposed Rule to take effect on January 1, 2008 unless final rule issued01-01-2008

Law took effect 1/1/08
Federal Register published 1/3/08
HTML or PDF

Final Rule Federal Register published 10/28/08
HTML or PDF

Federal Register notice on agency collection acitivities, comment request, and experimental study published 11/26/08; comments due 1/26/09
HTML or PDF
Guidance Federal Register notice published 6/8/09
HTML or PDF

Guidance 

CDER – Lisa Mathis
505Tracking of Assessments and Labeling Changes in a public information web site Pediatric Labeling Changes web siteCDER – Lisa Mathis
601Appoint Board of Foundation10-27-2007Appointed Board of FoundationOC – Lisa Rovin
602Create Office of the Chief Scientist, appoint Chief Scientist, includes an array of coordination and tracking duties 

Completed on April 9, 2008

Appointment of Dr. Frank M. Torti announced on 4/9/08

 

Dr. Jesse Goodman appointed Acting Chief Scientist announced on 4/13/09 

OC
701Develop and implement strategies for outreach and recruitment of advisory committee members CompletedOPPP
701Determine for FY 07 the total number of advisory committee members participating in meetings and the number who received an exception; determine the percentage receiving exceptions CompletedOPPP
701Submit to Congress a report on the number of vacancies and disclosures related to Advisory Committees

02-01-2008

 

02-01-2009

Report to Congress sent 5/19/08

 


Report to Congress sent 05/19/09
PDF

OPPP
701Publicly disclose the nature and amount of a committee member's financial interest and the justification for the waiver 

Draft Guidance for the Public published 10/31/07

Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers; Federal Register notice published 8/5/08
HTML or PDF

OPPP - Jill Hartzler Warner
701Review guidance regarding advisory committee conflict of interest waiver determinations Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees; Federal Register notice published 8/5/08
HTML or PDF
OPPP - Jill Hartzler Warner
801Ensure that the registry includes links to the results of efficacy trials or trials conducted post-approval, any FDA Advisory Committee summaries, and FDA Public Health Advisories12-26-2007Links available for clinical trials registry at clinicaltrials.govOSHI – Terry Toigo
FDA AA CLINICAL TRIALS
801NIH is to hold a public meeting to provide an opportunity for input from interested parties with regard to regulations for expanded registry and results data bank03-25-09

The public meeting will be held on Monday, April 20, 2009 from 9:00am to 5:00pm

NIH Federal Register Notice
 

 
801Update investigational drug regulations to include in informed consent documents that a statement certifying that clinical trial information has or will be submitted to registry12-29-09The Notice of Proposed Rulemaking (NPRM) proposing the update to FDA's informed consent regulations was published on 12/29/09.
HTML
OSHI – Terry Toigo
FDA AA CLINICAL TRIALS
801Issue guidance on how certain requirements apply to pediatric post-market surveillance under 402(j) of the PHSA, as amended09-27-2008NIH guidance on PRS and U.S. Public Law 110-85
http://prsinfo.clinicaltrials.gov/fdaaa.html
OSHI – Terry Toigo
FDA AA CLINICAL TRIALS
801Submission of certification with applications and submissions to FDA12-26-2007

Federal Register Notice published 12/12/07
HTML or PDF

Draft certification guidance issued 4/08


Final certification guidance Federal Register notice published 1/21/09
HTML or PDF


Certification Form PDF


Final certification guidance issued 1/15/09
HTML or PDF

OSHI – Terry Toigo
FDA AA CLINICAL TRIALS
901Promulgate regulations related to expanded access for patients with serious or life-threatening conditions Final Rules for Expanded Access published 8/12/09
HTML
CDER
901Issue regulation on postmarketing studies and clinical trials 

Draft guidance Federal Register Notice published on 7/15/09
HTML or PDF
Draft Guidance

 

Final Guidance for required postmarketing studies and clinical trials published 3/31/11. Postmarketing Studies and Clinical Trials

CDER - Nancy Clark
901Issue regulations on the standards for determining whether advertisements are clear, conspicuous, and neutral as it relates to side effects and contraindications03-25-2010

Federal Register notice on Agency Information Collection Activities published on 8/6/08; comments due 9/5/08
HTML or PDF

Federal Register notice on Agency Information Collection Activities published on 12/30/08; comments due 1/29/09
HTML or PDF

 

Regulation published 3/29/10 - Federal Register notice PDF

CDER – Tom Abrams
901Report to Congress on the ability of DTC ads to communicate to subsets of the general population. 

Report to Congress: Direct-to-Consumer Advertising’s Ability to Communicate to Subsets of the General Population; Barriers to the Participation of Population Subsets in Clinical Drug Trials
4/16/10

HTML or PDF

 

Comments Related to Required Report on Direct-to-Consumer Advertising Federal Register notice published on 4/28/08
HTML or PDF

CDER – Tom Abrams
901Recommendations to be included in
Report to Congress addressing best practice approaches on increasing
participation of subsets of the population in clinical drug trials
 

Report to Congress: Direct-to-Consumer Advertising’s Ability to Communicate to Subsets of the General Population; Barriers to the Participation of Population Subsets in Clinical Drug Trials
4/16/10

HTML or PDF

 

Participation of Certain Population Subsets in Clinical Drug Trials Federal Register notice published 1/13/09; Comments due 2/27/09
HTML or PDF

OC – Jarilyn Dupont
901Guidance on format and content that should be used for submissions of proposed REMS Draft guidance Federal Register notice published on 10/1/09
HTML or PDF
Draft Guidance
CDER - Kathleen Frost and CBER - Stephen Ripley
904Report to Congress on how best to communicate risk-benefit and REMS to the public09-27-2008Report to Congress sent on August 31, 2009. Completed 8/31/09 PDFCDER – Theresa Mullin
905Report to Congress on use of post-market surveillance system09-27-2011

This report was completed on 8/19/11. 

PDF

CDER – Melissa Robb
905Procedures for routine contracting with qualified entities for advanced analysis of drug safety data03-25-2011
As of 9/8/10: Cooperative agreement awarded to Brookings to convene meetings on active medical product surveillance Mini-Sentinel Federal Partners Collaboration.
 
CDER – Melissa Robb
906Conduct study in consultation with advisory committee on risk communication to determine if adverse event statement is appropriate for TV ads03-25-2008

Report delivered to Congress 5/12/08.
PDF

Federal Register Notice published on 11/26/08
HTML or PDF
 

CDER – Tom Abrams
909Certain drugs deemed to have REMS 

Federal Register Notice published on 3/27/08
HTML or PDF

 

9/24-25/09 Public Workshop Federal Register Notice published 7/10/09; register by 8/17/09
HTML or PDF

 

CDER – Mary Dempsey
911Issue guidance on conducting clinical trials involving antimicrobials to treat acute bacterial sinusitis.09-27-2008Clinical Trials involving Antimicrobials Acute Bacterial Sinusitis Guidance (final) published on 10/1/12 

PDF

CDER – Ed Cox
911Issue guidance on conducting clinical trials involving antimicrobials to treat acute bacterial otitis media.09-27-2008Clinical Trials involving Antimicrobials to Treat Acute Bacterial Otitis Media Guidance (final) published on 10/2/12.  PDFCDER – Ed Cox
911Issue guidance on conducting clinical trials involving antimicrobials to treat acute bacterial exacerbation of chronic bronchitis.09-27-2008Conducting clinical trials involving antimicrobials to treat acute bacterial exacerbation of chronic bronchitis Guidance (final) published on 10/5/12.  PDFCDER – Ed Cox
912Prohibit the introduction into interstate commerce any food to which has been added certain drugs or biological products, unless the drug or biological product meets certain requirements 

Federal Register Notice published on 7/29/08; comments due 10/27/08

HTML or PDF

CFSAN – Catherine L. Copp
913Develop standardized numerical identifier for prescription drugs and develop standards for identification, validation, authentication, and tracking/tracing of Rx drugs03-27-2010

Federal Register Notices published on 3/20/08: FDA-2008-N-0120
HTML or PDF
FDA-2008-N-0121
HTML or PDF

Federal Register Notice published 1/16/09; HTML or PDF

 

Final Guidance for Industry: Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages (March 2010) HTML or PDF

Federal Register Notice published on 3/29/10 PDF

 

 

Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Public Workshop (February 15-16, 2011)

Federal Register Notice published on 1/7/11 HTML or PDF

OPPP - Ilisa Bernstein
914Annual Report to Congress on delays in approvals because of citizen petitions 

First annual report to Congress sent on April 28, 2009.  HTML or PDF 

Second annual report to Congress sent on February 19, 2010 HTML or PDF

Third annual Report to Congress sent on June 30, 2011. HTML or PDF

CDER – Nancy Hayes
914

Report to Congress on ways to encourage the early submissions of petitions under Section 505(q)

 

09-27-2008

Draft Guidance for Industry on Citizen Petitions and Petitions Federal Register notice published 1/21/09; comments due 3/23/09
HTML or PDF

Report to Congress: Encouraging Early Submission of Citizen Petitions and Petitions for Stay of Action 4/2/09 HTML or PDF

Final Guidance for Industry: Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act published 6/8/11 PDF

CDER – Kim Thomas
915Develop an internet web site that provides drug safety information to patients and providers by: including searchable drug safety info, patient labeling and package inserts, lists of each drug, link to clinical trial registry data bank, submission of adverse event reports through the Internet etc.09-27-2008Postmarket Drug Safety Information for Patients and Providers web site published 10/15/08CDER - Sally Winthrop
917Establish the Advisory Committee on Risk Communication 

Risk Communication Advisory Committee established 6/5/07.

2008 Meetings were held on:
February 28 - 29
May 15 - 16
August 14 - 15

2009 Meetings were held on:
February 26 - 27
April 30 - May 1

OPL - Lee Zwanziger
918Referral to Advisory Committee Draft Guidance for the Public and the Food and Drug Administration Staff on Convening Advisory Committee Meetings; Federal Register notice published 8/5/08; comments due 10/6/08
HTML or PDF
OPPP - Jill Hartzler Warner
919Issue a report in response to the 2006 Institute of Medicine report09-27-2008 IOM report completed on July 17, 2009 PDFCDER – Jane Axelrad
920Publish a complete list of authorized generic drugs and notify certain federal agencies06-27-2008

Published FDA Listing of Authorized Generics on 6/27/08. 

 

Proposed rule Federal Register notice published 9/29/08
HTML or PDF

 

Withdrawal of the Direct Final Rule Federal Register notice published 2/10/09
HTML or PDF
 

CDER – Helen Winkle
921Report to Congress on how the Agency addresses post-market safety issues09-27-2009 Report to Congress sent on 11/7/11. PDFCDER
921Post a quarterly report on the Adverse Event Reporting System web site of any new safety information - 

Updated quarterly

AERS web site

 

CDER - Ann McMahon
921Annual Report to Congress on the Review Entire of Backlog of Postmarket Safety Commitments to Evaluate which require Revision/Elimination 

First annual report sent to Congress 9/4/09. PDF

Second sent 11/10/10. PDF

Third annual Report to Congress sent on October 4, 2012. PDF

CDER – Cathryn Lee
1002Regulation for (1) Ingredient Standards and Definitions; (2) Processing Standards; and (3) Labeling Standards Including nutritional and ingredient information09-27-2009Federal Register Notice published on 4/21/08; comments due 6/13/08
HTML or PDF

5/13/08 Public Meeting transcripts
CVM -
Tracey Forfa
1002Early Warning Surveillance System09-27-2008

Pet Food Recalls: Main web site

Pet Food Recalls: Searchable web site

Reporting a Pet Food Complaint:Safety Reporting Portal 

 

 

CVM
1003Ensuring efficient and effective communication during a recall. Create searchable public database for recalled human and pet foods.  ORA -Carolyn Becker
1005Establish a Reportable Food Registry to which instances of reportable food may be submitted via an electronic portal and a unique number is issued to the person submitting the report upon receipt09-27-2008

Federal Register Notice published on 5/27/08; comments due 8/11/08
HTML or PDF

Draft Guidance Federal Register Notice published on 6/16/09; comments due 7/16/09
HTML
or PDF

Federal Register notice published on 6/26/09
HTML or PDF

Public Workshops:
7/23/09 (College Park, MD)
8/5/09 (Chicago, IL)
8/25/09 (Oakland, CA)

Federal Register Notice of Availability published on 9/9/09
HTML
Final Guidance


Reportable Food Registry

 

A New Approach to Targeting Inspection Resources and Identifying Patterns of Adulteration: The Reportable Food Registry

 

 

CFSAN – Faye Feldstein

 

 

 

 

 

 

CFSAN - Juanita Yates (public workshop questions)

 

1005Issue guidance to industry about how to submit reports to the electronic Reportable Food Registry and providing notifications to other persons06-27-2008 CFSAN – Faye Feldstein
1006Report to Congress on specifics of aquaculture and seafood inspection program, the feasibility of developing a traceability system and provide an assessment of risks associated with particular contaminants and banned substances03-25-2008Report to Congress sent 11/24/08
HTML
CFSAN – Donald Kraemer
1007Work with NOAA to produce report on environmental risks associated with genetically engineered seafood  CVM
1009Annual Report to Congress on FDA food regulation and inspection for the preceding year  ORA - Carolyn Becker
1010Submit to Congress and publish on FDA web site a report concerning pesticide residue monitoring program06-01-2008

Pesticide Program Pesticide Monitoring Database 2007 published on 7/31/09.
HTML

Reports published on 8/4/08.
FDA Pesticide Program Residue Monitoring 2004-2006 Reports
HTML

Ginseng Dietary Supplements Special Survey (CFSAN Assignments and Field Regulatory Monitoring
for FY 2003 and FY 2004)
HTML

CFSAN – Nega Beru
1010Commissioner of Food and Drugs, the Administrator of the Food Safety and Inspection Service, the Department of Commerce and the head of the Agricultural Marketing Service shall enter into a memorandum of understanding to permit inclusion of data in reports related to testing carried out by FSIS and AMS  CFSAN – Nega Beru
1101Make publicly available written procedures to implement policy on review and clearance of scientific articles  SMG 2126.3 Review of FDA-Related Articles and Speeches HTMLOC/OCS – Matt Warren
1102Establish the amount of a priority review user fee for priority review voucher program09-30-2008

12/12/08 Public Hearing Notice published on 11/6/08; requests for oral presentations and comments due 11/17/08
HTML or PDF

Draft Guidance for Industry:
Tropical Disease Priority Review Vouchers published on 10/20/08 and added to the FDA web site on 10/28/08
PDF

CDER – Theresa Mullin
1111Make available on FDA web site any clinically susceptible concentrations (values that characterize bacteria) 

Federal Register Notice published on 6/12/08; comments due 8/11/08
HTML or PDF

 

Final Guidance published 6/26/09.

PDF

CDER – Nancy Boocker
1112Convene a public meeting re: serious and life-threatening diseases due to antimicrobial resistance 

Notice of April 28, 2008 Public Hearing and Request for Comments;
Federal Register Notice published on 4/15/08
HTML or PDF

 

CDER – Ed Cox
1113Publication of List developed by USP pursuant to Section 1860D-4(b)(3)(C)(ii) of the Social Security Act 

USP Model Guidelines - in effect as of September 27, 2007

HTML or PDF
 

CDER

 

 

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